Clincosm LogoSign in Get a demo

A Study of LY3857210 in Healthy Participants

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05292040
Collaborator
(none)
25
Enrollment
1
Location
1
Arm
6.5
Anticipated Duration (Months)
3.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main purpose of this study is to evaluate the presence of study drug LY3857210 in the brain measured by positron emission tomography (PET) with the radioligand [18F]-LY3818850 in healthy participants. The safety and tolerability of LY3857210 will also be evaluated. The study will last up to approximately 6 weeks for each participant and may include up to four visits to the study center.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
25 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
An Adaptive Design, Phase 1, Open-label Study to Investigate Receptor Occupancy in Brain After Single Oral Doses of LY3857210 as Measured by Positron Emission Tomography (PET) With the Radioligand [18F]-LY3818850 in Healthy Participants
Actual Study Start Date :
Mar 17, 2022
Anticipated Primary Completion Date :
Sep 30, 2022
Anticipated Study Completion Date :
Sep 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: LY3857210

Single doses of LY3857210 administered orally.

Drug: LY3857210
Administered orally.

Outcome Measures

Primary Outcome Measures

  1. Change from baseline in brain receptor occupancy (RO) of LY3857210 measured by [18F]-LY3818850 PET scan [Baseline through study completion, up to approximately 6 weeks]

    Change from baseline in brain RO of LY3857210 measured by [18F]-LY3818850 PET scan

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • Overtly healthy male or female participants as determined by medical evaluation

  • Have body weight ≥ 45 kilograms (kg) and body mass index (BMI) within the range 18.5 to 32.0 kilograms per square meter (kg/m²) (inclusive)

  • Are males and in agreement to follow contraceptive requirements, or women of non-child-bearing potential

Exclusion Criteria:

  • Have contraindications to undergoing magnetic resonance imaging (MRI) examination including but not limited to implants such as implanted cardiac pacemakers or defibrillators, insulin pumps, cochlear implants, metallic ocular foreign body, implanted neural stimulators, CNS aneurysm clips, and other medical implants that have not been certified for head MRI

  • Have clinically significant findings on the screening MRI scan, as judged by the investigator

  • Suffer from claustrophobia and would be unable to tolerate the confined spaces of MRI or PET camera

Contacts and Locations

Locations

Site City State Country Postal Code
1 Invicro, Institute for Neurodegenerative Disorders New Haven Connecticut United States 06510

Sponsors and Collaborators

  • Eli Lilly and Company

Investigators

  • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT05292040
Other Study ID Numbers:
  • 18313
  • J3O-MC-LSBA
First Posted:
Mar 23, 2022
Last Update Posted:
Jul 21, 2022
Last Verified:
Jul 15, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jul 21, 2022